Device and method for assessing asthma and other diseases

Abstract

Device and method for non-invasively monitoring asthma and other respiratory diseases, as well as non-respiratory diseases. The method includes collecting condensate from a subject's breath, testing the condensate to determine its acetic acid/acetate level or concentration, and evaluating these properties to determine the presence, absence or status of a respiratory or non-respiratory disease in the subject. The method may also include, prior to the testing step, standardizing the volatile substances that may be present within the condensate in a degassing or gas standardizing step. The device includes a mouthpiece apparatus configured to receive breath from a subject, a condensation apparatus to condense the subject's breath and produce a condensate, and a collection apparatus having a collection chamber containing means for testing the condensate to determine the acetic acid and/or acetate concentration. The device may also include a system for removing or standardizing the volatile substances that may be present with the condensate. The device and method may be utilized without condensing a subject's breath and collecting the same.

1. A method for assessing a disease in a subject, said method comprising:
 collecting condensate from a subject's breath, said condensate having an acetic acid or acetate concentration or both an acetic acid and acetate concentration; 
 testing said condensate to determine said acetic acid or acetate concentration or both said acetic acid and acetate concentrations; and 
 evaluating said acetic acid or acetate concentration or both said acetic acid and acetate concentrations to determine the presence, absence or status of a disease in the subject. 
 
   
   
     2. The method of  claim 1 , wherein said disease is a respiratory disease. 
   
   
     3. The method of  claim 2 , wherein said step of evaluating said acetic acid or acetate concentration or both said acetic acid and acetate concentrations to determine the presence, absence or status of a respiratory disease in the subject comprises determining the presence, absence or status of an inflammatory respiratory disease. 
   
   
     4. The method of  claim 3 , wherein said step of determining the presence, absence or status of an inflammatory respiratory disease comprises determining the presence, absence or status of asthma. 
   
   
     5. The method of  claim 2 , wherein said step of determining the presence, absence or status of a respiratory disease comprises determining the presence, absence or status of a respiratory disease that is a member of the group consisting of asthma, bronchiolitis, chronic obstructive pulmonary, bronchiectasis, common cold, cystic fibrosis, smoking induced diseases, tuberculosis, and occupational lung diseases. 
   
   
     6. The method of  claim 1 , wherein said step of determining said acetic acid or acetate concentration or both acetic acid and acetate concentrations of said condensate comprises using means for testing said condensate to determine said acetic acid or acetate concentration or both acetic acid or acetate concentrations. 
   
   
     7. The method of  claim 6 , wherein said step of using means for testing said condensate to determine said acetic acid or acetate concentration or both said acetic acid and acetate concentrations comprises using at least one of at least one electronic acetic acid monitor and at least one acetate monitor and at least one acetic acid and acetate monitor. 
   
   
     8. The method of  claim 6 , wherein said testing means comprise at least one acetic acid selective electrode. 
   
   
     9. The method of  claim 6 , wherein said step of using means for testing said condensate to determine said acetic acid or acetate concentration or both said acetic acid and acetate concentrations comprises using at least one ultraviolet/visible spectroscopy system. 
   
   
     10. The method of  claim 6 , wherein said step of using means for testing said condensate to determine said acetic acid or acetate concentration or both said acetic acid or acetate concentrations comprises using at least one of at least one mass spectroscopy system and at least one gas chromatography mass spectroscopy system. 
   
   
     11. The method of  claim 6 , wherein said step of using means for testing said condensate to determine said acetic acid or acetate concentration or both said acetic acid and acetate concentrations comprises using at least one artificial nose system. 
   
   
     12. The method of  claim 6 , wherein said step of using means for testing said acetic acid or acetate or both said acetic acid and acetate condensate to determine said acetic acid or acetate concentration or both said acetic acid and acetate concentrations comprises introducing at least one reagent to said condensate. 
   
   
     13. The method of  claim 1 , wherein said condensate comprises volatile substances, and said method further comprises standardizing said volatile substances within said condensate prior to said testing step. 
   
   
     14. The method of  claim 13 , wherein said step of standardizing said volatile substances within said condensate comprises a gas standardizing step. 
   
   
     15. The method of  claim 13 , wherein said step of standardizing said volatile substances within said condensate comprises a degassing step. 
   
   
     16. The method of  claim 15 , wherein said degassing step comprises introducing an inert gas to said condensate. 
   
   
     17. The method of  claim 1 , wherein said step of collecting condensate from a subject's breath comprises collecting condensate from a human or an animal subject. 
   
   
     18. The method of  claim 1 , wherein said step of collecting condensate from a subject's breath comprises condensing breath that has been exhaled through the subject's mouth. 
   
   
     19. The method of  claim 1 , wherein said step of collecting condensate from a subject's breath further comprises condensing breath that has been exhaled through the subject's nose or both nose and mouth. 
   
   
     20. The method of  claim 1 , wherein said step of collecting condensate from a subject's breath further comprises condensing breath that has been exhaled through the subject's endotrachial tube or tracheostomy tube. 
   
   
     21. The method of  claim 1 , wherein said step of collecting condensate from a subject's breath comprises:
 introducing the subject's breath into a condensation apparatus, said condensation apparatus producing a condensate from said breath; and 
 moving said condensate into a collection apparatus. 
 
   
   
     22. The method of  claim 21 , wherein said step of moving said condensate into a collection apparatus comprises moving said condensate by force of gravity. 
   
   
     23. The method of  claim 21 , wherein said step of moving said condensate into a collection apparatus comprises moving said condensate using a pump. 
   
   
     24. The method of  claim 1 , wherein said step of collecting condensate from a subject's breath comprises:
 introducing a sample of said breath into a condensation apparatus capable of producing a condensate from said breath; and 
 collecting said condensate produced by said condensation apparatus in said condensation apparatus. 
 
   
   
     25. The method of  claim 1 , wherein said step of collecting condensate from a subject's breath comprises:
 providing a cooled condensation apparatus; and 
 introducing a sample of said breath into said cooled condensation apparatus. 
 
   
   
     26. The method of  claim 25 , wherein said cooled condensation apparatus has a temperature at least as low as about 10° C. 
   
   
     27. The method of  claim 25 , wherein said cooled condensation apparatus has a temperature at least as low as about −80 C. 
   
   
     28. The method of  claim 1 , wherein said step of evaluating said acetic acid or acetate concentration or both said acetic acid and acetate concentrations to determine the presence, absence or status of a disease in the subject comprises evaluating said acetic acid or acetate concentration or both said acetic acid and acetate concentrations to diagnose at least one of at least one respiratory disease and at least one non-respiratory disease in the subject. 
   
   
     29. The method of  claim 28 , wherein said step of evaluating said acetic acid or acetate concentration or both said acetic acid and acetate concentrations to determine the presence, absence or status of at least one of at least one respiratory disease and at least one non-respiratory disease in the subject comprises evaluating said acetic acid or acetate concentration or both said acetic acid and acetate concentrations to determine the severity of said respiratory and non-respiratory disease in the subject. 
   
   
     30. The method of  claim 28  wherein said step of evaluating said acetic acid or acetate concentration or both said acetic acid and acetate concentrations to determine the presence, absence or status of at least one of at least one respiratory disease and at least one non-respiratory disease in the subject comprises evaluating said acetic acid or acetate concentration or both said acetic acid and acetate concentrations to determine whether a course of treatment for said respiratory and non-respiratory disease in the subject should be started, altered or discontinued. 
   
   
     31. The method of  claim 28 , wherein said step of evaluating said acetic acid or acetate concentration or both said acetic acid and acetate concentrations to determine the presence, absence or status of at least one of at least one respiratory disease and at least one non-respiratory disease in the subject comprises evaluating said acetic acid or acetate concentration or both said acetic acid and acetate concentrations to predict an impending exacerbation of said respiratory or non-respiratory disease in the subject. 
   
   
     32. A method for assessing asthma in a subject, comprising:
 providing a device comprising a mouthpiece apparatus, a condensation apparatus and a collection apparatus; 
 receiving a subject's breath in said mouthpiece apparatus; 
 condensing said breath in said condensation apparatus to form a condensate; 
 collecting said condensate in said collection apparatus; 
 testing said condensate within said collection apparatus to determine acetic acid or acetate concentration or both said acetic acid and acetate concentrations; and 
 evaluating said acetic acid or acetate concentration or both said acetic acid and acetate concentrations to determine the presence, absence or status of asthma in the subject. 
 
   
   
     33. A method for assessing asthma in a subject, comprising:
 providing a device comprising a mouthpiece apparatus and a condensation apparatus; 
 receiving a subject's breath in said mouthpiece apparatus; 
 condensing said breath in said condensation apparatus to form a condensate; 
 collecting said condensate in said condensing apparatus; 
 testing said condensate within said condensation apparatus to determine acetic acid or acetate concentration or both said acetic acid and acetate concentrations; and 
 evaluating said acetic acid or acetate concentration or both said acetic acid and acetate concentrations to determine the presence, absence or status of asthma in the subject. 
 
   
   
     34. A device for assessing a disease in a subject, said device comprising:
 a mouthpiece apparatus configured to receive breath from a subject; 
 a condensation apparatus configured for operative connection to said mouthpiece apparatus, and being further configured to condense the subject's breath and produce a condensate having acetic acid or acetate or both said acetic acid and acetate; and 
 a collection apparatus configured for operative connection to said condensation apparatus, said collection apparatus comprising a collection chamber containing means for testing said condensate to determine said acetic acid or acetate concentration or both said acetic acid and acetate concentrations, wherein the subject's breath may be received, condensed and evaluated in a single device to determine the presence, absence or status of a disease in the subject. 
 
   
   
     35. The device of  claim 34 , wherein said means for testing said condensate comprises a reagent disposed within said collection chamber. 
   
   
     36. The device of  claim 35 , wherein said reagent is a solid reagent. 
   
   
     37. The device of  claim 35 , wherein said condensate has acetic acid or acetate concentration or both said acetic acid and acetate concentrations and said reagent is useful for measuring said acetic acid or acetate concentration or both said acetic acid and acetate concentrations of said condensate. 
   
   
     38. The device of  claim 35 , wherein said means for testing said condensate comprises a reagent chamber containing at least one reagent. 
   
   
     39. The device of  claim 35 , wherein said means for testing said condensate comprises a retainer configured to hold a material, said material comprising a reagent. 
   
   
     40. The device of  claim 34 , wherein said means for testing said condensate comprises an electrode of an electronic monitor. 
   
   
     41. The device of  claim 40 , wherein said electronic monitor is configured to connect to said collection chamber. 
   
   
     42. The device of  claim 34 , wherein said collection chamber is detachable and disposable. 
   
   
     43. The device of  claim 42 , wherein said collection chamber comprises a plastic test tube. 
   
   
     44. The device of  claim 34 , wherein said collection chamber comprises a measuring gradient in communication therewith. 
   
   
     45. The device of  claim 34 , wherein said mouthpiece apparatus comprises proximal end, a distal end, and a mouthpiece disposed at said proximal end of said mouthpiece apparatus. 
   
   
     46. The device of  claim 45 , wherein said mouthpiece apparatus further comprises a first one-way valve configured to permit air to be drawn into said mouthpiece apparatus, and a second one-way valve configured to permit air to pass from said mouthpiece to said distal end of said mouthpiece apparatus. 
   
   
     47. The device of  claim 46 , wherein said mouthpiece apparatus further comprises a particle filter disposed between said mouthpiece and said distal end of said mouthpiece apparatus. 
   
   
     48. The device of  claim 34 , wherein said condensation apparatus comprises an inner tube surrounded by an insulator. 
   
   
     49. The device of  claim 48 , wherein:
 said inner tube has an outer surface; and 
 said condensation apparatus further comprises an outer tube disposed between said inner tube and said insulator, said outer tube having an inner surface, and said inner surface of said outer tube and said outer surface of said inner tube defining a heat transfer chamber. 
 
   
   
     50. The device of  claim 49 , wherein said heat transfer chamber contains a cooling material. 
   
   
     51. The device of  claim 50 , wherein said outer tube has a first port therein providing access to said heat transfer chamber, and a second port therein providing access to said heat transfer chamber, wherein said cooling material may be inserted into said heat transfer chamber through said first port and removed through said second port. 
   
   
     52. The device of  claim 49 , wherein said inner tube is made of aluminum, said outer tube is made of plastic and said insulator is made of foam plastic. 
   
   
     53. The device of  claim 34 , wherein said collection apparatus further comprises a connector portion configured to connect said collection chamber to said condensation apparatus. 
   
   
     54. The device of  claim 53 , wherein said connector portion comprises a T-connector having a first T-portion and a second T-portion, said first T-portion being configured to connect said T-connector to said collection chamber and said second T-portion providing a port to atmosphere, wherein uncondensed breath passing through said condensation apparatus and into said T-connector may vent to atmosphere. 
   
   
     55. The device of  claim 54 , wherein said device further comprises an apparatus to standardize volatile substances within said condensate. 
   
   
     56. The device of  claim 55 , wherein said apparatus to standardize volatile substances within said condensate comprises a degassing apparatus. 
   
   
     57. The device of  claim 56 , wherein said degassing apparatus comprises a pump. 
   
   
     58. A device for assessing a disease in a subject, said device comprising:
 a mouthpiece apparatus configured to receive breath from a subject; 
 a condensation apparatus configured for operative connection to said mouthpiece apparatus, and being further configured to condense and collect the subject breath and produce a condensate having acetic acid or acetate concentration or both said acetic acid and acetate concentrations; and 
 said condensation apparatus comprising a means for testing said condensate to determine said acetic acid or acetate concentration or both said acetic acid and acetate concentrations. 
 
   
   
     59. The device of  claim 58 , wherein said means for testing said condensate comprises a reagent disposed within said collection chamber. 
   
   
     60. The device of  claim 58 , wherein said means for testing said condensate comprises an electrode of an electronic monitor. 
   
   
     61. The device of  claim 58 , wherein said condensation apparatus is detachable and disposable. 
   
   
     62. A method for assessing a disease in a subject, said method comprising:
 said subject exhaling through a measuring device or substance, said measuring device or substance effective for detecting acetic acid or acetate or both acetic acid and acetate; 
 testing said detected acetic acid or acetate or both said detected acetic acid and acetate to determine said acetic acid or acetate concentration or both said acetic acid or acetate concentrations; and 
 evaluating said acetic acid or acetate concentration or both said acetic acid and acetate concentrations to determine the presence, absence or status of a disease in the subject. 
 
   
   
     63. The method of  claim 62 , wherein said measuring device or substance is a reagent, said reagent effective for trapping acetic acid or acetate or both acetic acid and acetate. 
   
   
     64. The method of  claim 63 , wherein said reagent is a solution or a solid or both. 
   
   
     65. The method of  claim 64 , wherein said reagent is a base. 
   
   
     66. The method of  claim 65 , wherein said base comprises Sodium Hydroxide, or any of several potential single or combined compounds that together have the ability to consume protons and thereby alkalinize a water. 
   
   
     67. The method of  claim 62 , wherein said measuring device or substance is a spectroscopy system, electrode, chemical reagent strip or artificial nose for detecting acetic acid or acetate or both acetic acid and acetate. 
   
   
     68. The method of  claim 62 , wherein said disease comprises at least one of at least one respiratory disease and at least one non-respiratory disease in the subject. 
   
   
     69. A device for assessing a disease in a subject, said device comprising:
 a mouthpiece apparatus configured to receive breath from a subject; 
 a measuring device or substance configured for operative connection to said mouthpiece apparatus, said measuring device or substance effective for detecting acetic acid or acetate concentration or both said acetic acid and acetate concentrations from said subject's breath; 
 a means for testing said trapped acetic acid and acetate to determine said acetic acid or acetate concentration or both said acetic acid and acetate concentrations; and 
 an evaluating means for evaluating said acetic acid or acetate concentration or both said acetic acid and acetate concentrations to determine the presence, absence or status of a disease in the subject. 
 
   
   
     70. The device of  claim 69 , wherein said measuring device or substance is a reagent, spectroscopy system, electrode, or artificial nose for detecting acetic acid or acetate or both acetic acid and acetate. 
   
   
     71. The method of  claim 69 , wherein said disease comprises at least one of at least one respiratory disease and at least one non-respiratory disease in the subject.